Guidant (Indianapolis, Indiana) implanted its first Contak Renewal system, what it termed the company's "most advanced heart failure therapy system." The device contains new diagnostic capabilities that are designed to help physicians better manage their patients' condition by capturing information that is relevant to physician decision-making. The device monitors heart rate variability, a tool designed to track and measure the status of heart failure patients. Additionally, the system uses data from an accelerometer sensor to track trends in patients' activity levels.
Raymond Yee, MD, director of arrhythmia services at London Health Science Center (London, Ontario) performed the first implant of the device. The patient was a 72-year-old woman suffering from idiopathic dilated cardiomyopathy. The device provides cardiac resynchronization therapy, which is designed to enhance pumping function and defibrillation capability. Guidant said that the FDA has completed an initial review of its PMA and determined that it is suitable for filing.
The company also said it has received FDA approval of its fifth broad-use coronary stent system, the Multi-Link Penta. It will begin introducing the stent to physicians in the U.S. this month. The new stent features Guidant's Access-Link technology, developed to allow the stent to be flexible enough to be maneuvered through a patient's vessels while still retaining the strength needed to prop open a previously blocked artery. It is mounted on a delivery system with the new Wrap balloon, which is designed to allow the system to be more easily delivered to the site of the blockage.
Elsewhere in the product pipeline:
Arrow International (Reading, Pennsylvania) said that two additional patients have received a LionHeart implant, the company's fully implantable Left Ventricular Assist System (LVAS), since the company's last update in March. One patient received the device in Bad Oeyenhausen, Germany, where a total of six devices have now been implanted. The second patient received the device at the University of Pennsylvania Medical Center (Philadelphia, Pennsylvania). This was the second patient to enter the seven patient U.S. feasibility trial authorized under an FDA investigational device exemption. The surgery was performed in mid-April, and the patient is recovering as expected. The first U.S. recipient of the LionHeart received the device on Feb. 28 at Penn State Milton S. Hershey Medical Center (Hershey, Pennsylvania). The company said that the device, which is capable of taking over the entire workload of the left ventricle, represents a significant advance in mechanical circulatory assist technology. Because the Arrow LionHeart is the first fully implantable "destination therapy" device, the patient is likely to experience an improved quality of life for an extended period of time. It is fully implanted in the body and does not replace the heart, but assists in the pumping function of the heart's left ventricle. The device is electrically driven by a wearable battery pack that transmits power noninvasively through the skin to charge internal batteries and power the blood pump.
Boston Medical Technologies (Wakefield, Massachusetts) recently published the results of a study on heart rate variability (HRV) testing. According to the journal Diabetes Technology and Therapeutics, HRV is considered to be the most reliable and available indicator of autonomic nervous system function. The study, "Heart Rate Variability Measurement in Diabetic Neuropathy: Review of Methods," also reports reproducibility and normal ranges for the Anscore Health Management System, the company's HRV testing system for quantifying HRV. The Anscore Health Management System was evaluated in a study on 212 healthy individuals, aged 20-80, who performed three standard heart rate variability tests: Metronomic Breathing, Valsalva and Stand. The study was began in November 1999 and concluded in April 2000. The system garnered normal range results that the company said illustrate the importance of having machine-specific reference values so that reliable test results can be obtained. The study also demonstrated the system's ability to pinpoint subtle decreases in HRV as a person ages. Boston Medical Technologies is a developer of office and hospital-based, noninvasive heart rate variability testing systems to improve the quality and cost-effectiveness of clinical care.
Boston Scientific (Natick, Massachusetts) reported the launch of the Quantum Monorail post-dilatation balloon catheter in the U.S. The new catheter uses the balloon material found in the Quantum Ranger catheter. The material, called Quantum Leap, features Hinge Balloon Technology, which the company said offers sizing flexibility at lower pressures and minimal growth at higher pressures. This technology combines both non-compliant balloon properties with the performance characteristics of semi-compliant balloon catheters. The catheter is available in stent-matched lengths of 9 mm, 12 mm, 15 mm, 18 mm and 20 mm and in diameters from 2.5 mm to 4.0 mm.
Cook Biotech (CBI; St. Lafayette, Indiana) reported receiving a U.S. patent, No. 6,206,931, for graft devices including an improved and purified implantable biomaterial derived from extracellular matrix (ECM) taken from submucosal tissue. The CBI technology provides ECMs that can be implanted in humans without causing a toxic response, fever, rejection of the implant or other harmful effects. "Under this patent, CBI has shown a way to manufacture biocompatible ECMs with extremely high purity by removing almost all of the endotoxins, molecules that may cause fever and other reactions when implanted," said Michael Hiles, PhD, vice president of research for CBI.
Data Critical (Bothell, Washington) released its RhythmView, an integrated arrhythmia monitoring hardware and software package. The system allows cardiologists to set up a comprehensive 24-hour arrhythmia monitoring station in their office or hospital cardiac department, reducing, said the company, the need for outside arrhythmia monitoring services. RhythmView also provides cardiologists instant, mobile access to EKGs and patient data on a Compaq iPAQ Pocket PC. Based on the Paceart 2000 pacemaker follow-up system, the RhythmView system integrates Data Critical's Paceart Division's Arrhythmia Management and CardioVoice monitoring software with patient event recorders and Compaq hardware, including the iPAQ.
Eclipse Surgical Technologies (Sunnyvale, California) said its laser heart revascularization procedure won an important endorsement as a proven health benefit for patients from the Blue Cross and Blue Shield Association. Eclipse received confirmation from the Blue Cross/Blue Shield Technology Evaluation Center that the transmyocardial revascularization (TMR) laser procedure "improves net health outcomes" when performed as an adjunct to coronary artery bypass graft surgery. In FDA-approved TMR, surgeons use a laser to drill a series of tiny holes in the heart muscle, which are believed to stimulate new blood flow to the diseased area.
Gene Logic (Gaithersburg, Maryland) launched a new GeneExpress Suite research product, the GeneExpress Cardiovascular DataSuite. The Cardiovascular DataSuite is comprised of normal and diseased human cardiac and vascular tissues from a cross-section of individuals, races, medication regimens, lifestyles and disease stages.
Medtronic (Minneapolis) commercially released in the U.S. and Europe its new LocaLisa IntraCardiac Navigation system, the first of its kind to provide 3-D catheter localization capabilities without the need for special catheters, during ablation procedures. The system tracks up to 10 electrodes on multiple catheters and enables annotation of key areas and potential points of physiologic interest in three-dimensional space. Physicians may then use the new system to more accurately position ablation catheters. Steve Mahle, president, Medtronic Cardiac Rhythm Management, said, "The LocaLisa system has the potential to reduce X-ray exposure and ablation procedure time when compared to the traditional two-dimensional approach of using fluoroscopic-based imaging systems. In addition, other three-dimensional systems typically mandate the use of special catheters with built-in sensors. With the LocaLisa system, set-up time is minimal, no special sensors are required, and it is suitable for use in any cardiac ablation procedure."
Myocor (Maple Grove, Minnesota) reported the first U.S. human implants of the Myocor Myosplint, an implantable device designed to improve cardiac performance and efficiency in heart failure patients by changing the size and shape of the heart. The first U.S. Myosplint patients were two men diagnosed with Class III idiopathic dilated cardiomyopathy. The procedures were performed at the Cleveland Clinic Foundation (Cleveland, Ohio). In both procedures, three Myosplint devices, each of which consists of two pads that rest on the outside of the heart and are connected by a high-strength tension member, were placed down the length of the left ventricle. The device was used to draw the walls of the heart closer together, reshaping the heart and reducing its size by a prescribed amount. In both cases, the Myosplints were placed in approximately 45 minutes. The patients subsequently underwent procedures to repair leaking mitral valves and have since been discharged from the hospital. Up to 10 patients will receive Myosplint implants during a Phase I safety and feasibility trial authorized by the FDA and being conducted at the Cleveland Clinic Foundation (Cleveland, Ohio) and the University of Michigan Health System (Ann Arbor, Michigan). Myocor expects to begin a Phase II pivotal trial late in 2001. A European safety study began earlier this year, with a total of 14 human implants completed to date. The initial European implants were performed at University Heart Center (Leipzig, Germany) and Grosshadern Clinic (Munich, Germany). Heart failure affects about 13.5 million people in the U.S., Western Europe and Japan, with 1.4 million new cases diagnosed each year.
Possis Medical (Minneapolis, Minnesota) said the FDA has approved the re-start of patient enrollment in the TIME 1 (Thrombectomy In Middle Cerebral Artery Embolism) clinical trial for ischemic stroke, which is caused by blood clots occurring deep within the brain, resulting in death or substantially reduced quality of life. Possis has developed a highly miniaturized, flexible catheter, the NV150, to access the middle cerebral artery and rapidly remove clots. TIME 1 will enroll up to 30 patients at up to eight centers in the U.S. to determine safety of the device for that indication. As a result of the earlier treatment of five patients in TIME 1, there have been important refinements to both the device and to the trial protocol, which the FDA now has approved The co-principal investigators for the TIME 1 study are Dr. John Perl II and Dr. Anthony Furlan of the Cleveland Clinic Foundation.
Sigma Aldrich (St. Louis, Missouri) reported the launch of the Alpha Dx Point-of-Need System produced by First Medical to enhance its position in cardiac testing. The Alpha Dx System uses a patented technology that provides reliable results to diagnose acute myocardial infarction rapidly and cost-effectively. The company said the system, which will be used in hospital emergency departments, coronary care units and STAT laboratories, will revolutionize the management of chest pain patients. Quantitative results comparable to those currently provided by larger, laboratory analyzers that distinguish heart attacks from other causes of chest pain will be available in less than 18 minutes. The Point-of-Need System platform is extendible to other clinical decision support applications. Sigma Aldrich said the launch of the system is part of its Diagnostics Division strategy to enhance its portfolio in cardiac testing and the point-of-care market.
Spectranetics (Colorado Springs, Colorado) said that the 10,000th patient to be treated successfully with the company's lead removal products was a 57-year-old woman from whom four problematic pacemaker leads were removed during a procedure at the Cleveland Clinic Foundation.
St. Jude Medical (St. Paul, Minnesota) reported the release of new electrophysiology catheters and guiding introducers that can assist clinicians in the diagnosis of paroxysmal atrial fibrillation. The 4 Fr Supreme Spiral SC catheters are deployed into the left atrium via specialized Fast-Cath Duo guiding introducers allowing physicians to circumferentially map the ostia of the pulmonary veins. St. Jude said the catheter's spiral-shaped curve tips can assist the physician in identifying preferential entrance or exit points where atrial fibrillation propagates into the left atrium. The new catheter system allows two catheters to be deployed through a single transseptal puncture for the simultaneous mapping of a set of pulmonary veins.
Texas Biotechnology (Houston, Texas) and Henry Ford Health Systems (Detroit, Michigan) presented positive Argatroban data from a preclinical study in stroke. The data indicated that use of Argatroban and t-PA, the only medication approved for stroke, in combination four hours after the onset of embolic stroke, reduced ischemic lesion size without increasing gross cerebral hemorrhage rates.
ThromboGenics (Dublin, Ireland) announced the initiation of two clinical trials for SY162, a novel thrombolytic agent. One of these early Phase II trials will evaluate SY162 for the treatment of central venous catheter (CVC) occlusion, and the other will evaluate SY162 for the treatment of acute peripheral arterial occlusive disease (PAOD). The CVC trial will enroll approximately 48 patients, while the PAOD trial will enroll approximately 20 patients. Both trials are being performed in Belgium. Medisearch International has been contracted to monitor both trials. Acute PAOD is associated with significant mortality and morbidity. Treatment options include surgical intervention and intra-arterial administration of a thrombolytic agent. Intra-arterial thrombolysis has the potential advantage of reducing the need for surgery, or for patients who still require surgery after thrombolysis, permitting a less-extensive surgical procedure.